China’s SciClone Pharmaceuticals Inc., (HKG: 6600) has entered into a licensing and cooperation agreement with the Italy-headquartered Menarini Group. This agreement grants SciClone exclusive development and commercialization rights to Menarini’s Orserdu (elacestrant) in China. SciClone will be responsible for conducting clinical trials, regulatory filings, and marketing and distribution of Orserdu in China, following market approval. The financial details of the upfront payment and subsequent milestone payments, as well as tiered royalties based on net sales, remain undisclosed.
Background on Elacestrant and Menarini Group’s Rights
Elacestrant, a next-generation selective estrogen receptor degrader (SERD), was originally developed by Eisai and handed over to Radius Health for global development in 2006. Menarini secured a significant position in the global market by inking a licensing deal with Radius Health in July 2020, acquiring global exclusive commercialization rights to the drug. This positions SciClone to leverage Menarini’s expertise and Orserdu’s potential in the Chinese market.
Orserdu’s Approval and Indications
Orserdu has been approved in the US and Europe to treat estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (mBC) with ESR1 mutation. The drug’s approval in these regions in January and September of this year, respectively, highlights its potential impact on the treatment of breast cancer patients globally.-Fineline Info & Tech
